MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for BONEBRIDGE BCI BONE CONDUCTION IMPLANT manufactured by Med-el Elektromedizinische Geraete Gmbh.
[125439842]
The device has not been explanted. If it should be explanted, it is to be returned to the manufacturer for evaluation. When available, a device failure analysis will be submitted as a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[125439843]
The user is not able to hear with the device. Re-implantation is planned for (b)(6) 2018. According to additional information received the user was able to use the device for years with good benefit. There were no intermittencies, the device just stopped working suddenly. Blurred noise was heard when moving the head in a certain position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2018-00862 |
| MDR Report Key | 8013815 |
| Date Received | 2018-10-29 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-10-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA SIMONOTTI |
| Manufacturer Street | FUERSTENWEG 77A |
| Manufacturer City | INNSBRUCK 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal | 6020 |
| Manufacturer Phone | 57788 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONEBRIDGE |
| Generic Name | BCI BONE CONDUCTION IMPLANT |
| Product Code | PFO |
| Date Received | 2018-10-29 |
| Returned To Mfg | 2018-11-14 |
| Model Number | BCI BONE CONDUCTION IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH |
| Manufacturer Address | INNSBRUCK AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-29 |